Thanks George. I was unaware that the FDA had guided ANP that...

Thanks George. I was unaware that the FDA had guided ANP that accelerated approval WOULD BE GIVEN if the P2b trial successfully attained endpoints.

This explains why there was no mention of the European commercial path because there no longer is one, or it isn’t a focus at present (can be picked up later).

I wonder if Fast Track status has been applied for as it costs nothing. AFAIK it hasn’t been mentioned in announcements. Probably unnecessary at this stage in ATL1102’s development.

Makes it slightly fuzzy on no other treatment options if CAPR meet endpoints in HOPE-3 as they are targeting inflammation (albeit a different mechanism) in primarily non-ambulant phase (10+ years).

ODD protections are also only seven years in US as opposed to Europe 12 years. The reimbursement landscape is a lot simpler in the US though AFAIK.

Your post is a huge positive for me.